AccessGUDID - DEVICE: Seraclone® Anti-k (KEL2) (07611969951635)

GUDID

Device Identifier (DI) Information

Brand Name: Seraclone® Anti-k (KEL2)
Version or Model: 808125100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 808125100
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969951635
Issuing Agency: GS1
Commercial Distribution End Date: June 24, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Blood Grouping Reagent Anti-k (KEL2); Seraclone® Murine Monoclonal (Lk1); for tube test; 5ml

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45309	Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination	A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen to determine the Rh phenotype (CcDEe) [RH:1,2,3,4,5] and Kell phenotype [KEL:1,2] of red blood cells, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 515816c2-c92c-44b0-99e0-4dd159dde3a9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 24, 2015